FDA Inspection
Addition Technology IncAddition Technology Inc – FDA Inspection, Dec 15, 2008
Record Details
This FDA Inspection record concerns Addition Technology Inc, with an inspection on December 15, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Addition Technology Inc
- Inspection Date
- December 15, 2008
- Product Type
- Devices
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ID · d2d1fe28-d911-47ad-8e0f-c107abb5e8e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554460
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Addition Technology Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Addition Technology Inc
- FDA Inspection 1204379 - 2023-04-27
- FDA Inspection 1029535 - 2017-09-15
- FDA Inspection 942276 - 2015-09-11
- FDA Inspection 838149 - 2013-06-28
- FDA Inspection 653684 - 2010-03-24
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